Thrombectomy device and method of use thereof

Abstract

This disclosure provides devices and systems for performing thrombectomy and methods for using the same.

Description

[Background technology] 【0001】 Arteriovenous fistulas (AVFs) are a critical standard of treatment for patients with end-stage renal disease (ESRD) who require frequent dialysis. An AVF is an artificial shunt created by open or minimally invasive surgery in which an artery and a vein are directly connected to each other. Through this connection, the artery provides more pressure and blood flow to the vein than necessary, providing reliable access for dialysis. Alternatively, a fragment of synthetic tubing (i.e., a graft) may be used to create a shunt between the artery and the vein. Over time, blood clots may form in the venous outflow or within the graft, obstructing dialysis access. One method to reopen an AVF or arteriovenous graft (AVG) is to use a rotating thrombectomy device to break down the blood clot into smaller fragments and push them into the central venous system to confine and dissolve them in the pulmonary capillaries. However, currently available rotating thrombectomy devices have certain limitations. A first class of such devices (e.g., ARROW-TREROTOLA® PTD® devices) includes a self-expanding basket made of shape memory alloy (e.g., Nitinol), which, once placed in a blood vessel, expands to fit the size of the lumen. The basket is then rotated around its longitudinal axis using an electric handle while being moved back and forth within the container, thereby breaking up the blood clot into smaller pieces. Because this device has multiple contact points with the blood vessel wall, it is traumatic to the endothelium and can induce thrombosis by exposing the underlying collagen to the blood. In addition, it can induce vasospasm and interfere with the procedure. 【0002】 A second class of such devices (e.g., CLEANER™ thrombectomy devices) includes a single, sinusoidal-shaped, multi-filament wire that is actuated again using an electric handle to cryo-infuse the blood clot. This device is less traumatic to the blood vessel, but is accompanied by its own drawbacks. First, the device breaks the blood clot into larger fragments, which may embolize within the larger pulmonary arteries and cause pulmonary embolism. Second, the wires of these devices are flexible and deform when touching subacute or chronic blood clots, which are more consistent and harder than acute blood clots. As a result, this device has suboptimal effectiveness in decomposing blood clots. 【0003】 Finally, a common problem associated with both classes of rotary thrombectomy devices is that they have very limited effectiveness against blood clots trapped within a venous aneurysm dilation, which is a common phenomenon in dialysis access circuits. 【0004】 Another application of thrombectomy devices is the removal and recanalization of peripheral organ arteries in situations such as acute ischemic stroke (intracerebral) and acute ischemic myocardial infarction (intracardiac). These thrombectomy devices, commonly referred to as stent retrievers, are now standard treatment in the management of acute ischemic stroke and myocardial infarction. In such clinical settings, the stent retriever is navigated through a microcatheter to position itself through the blood clot occluding the artery. The stent retriever is then deployed by pulling back the microcatheter. The stent strut penetrates the blood clot, and the thrombus is embedded within the device. As the stent is retracted into the catheter, the thrombus trapped within the stent cell is removed along with the stent. While this technique works very well for the removal of acute blood clots, which are relatively flexible in consistency and can be penetrated by the stent strut, it has poor outcomes in about one-third (1 / 3) of cases with chronic blood clots. Such blood clots are largely composed of fibrous tissue that is highly elastic and does not allow the stent to penetrate the blood clot material. Instead, the clot pushes back the stent and prevents its engagement. 【0005】 Therefore, there is a need for improved thrombectomy devices that address these challenges. [Overview of the Initiative] 【0006】 This specification describes devices, systems, methods, and kits useful for removing vascular occlusions (e.g., thrombi) from subjects (e.g., thrombectomy). In particular, this disclosure features a spiral thrombectomy device for use in performing vascular thrombectomy. 【0007】 In one embodiment, the present disclosure features a thrombectomy device having a proximal end and a distal end defining a first axis, and having a length between the proximal end and the distal end, wherein a) the thrombectomy device includes a helical grid along the first axis, the helical grid includes a proximal end, a distal end, and a width extending along a second axis perpendicular to the first axis, b) the helical grid includes a network of grid cells, and c) the helical grid is configured to change between a compressed state (e.g., a deformed state) and an uncompressed state (e.g., an undeformed state) about the second axis, and the thrombectomy device further comprises a shaft. 【0008】 In some embodiments, the thrombectomy device is sized to traverse a blood vessel. In some embodiments, the helical grid includes about 1 to about 25 turns (e.g., 1 to 10 turns, 1 to 5 turns, or 3 turns). In some embodiments, each turn includes a pitch of about 1 mm to about 30 mm (e.g., about 1 mm to about 20 mm, about 5 mm to about 20 mm, or about 5 mm to 15 mm). In some embodiments, the helical grid is compressible around a first axis. In some embodiments, the grid cells are compressible. In some embodiments, the grid cells include polygonal, square, rectangular, triangular, rhombus, circular, elliptical, egg-shaped, oblong, lenticular, star-shaped, delta-shaped, slit-shaped, or amorphous shapes. In some embodiments, the helical grid (e.g., the material forming the structure of the helical grid) includes a thickness of about 0.01 mm to about 1 mm (e.g., a thickness of about 0.03 mm to about 0.8 mm, about 0.05 mm to about 0.6 mm, about 0.1 mm to about 0.4 mm, or about 0.2 mm to about 0.3 mm). 【0009】 In some embodiments, the helical grid self-expands from a compressed state to an uncompressed state (for example, the helical grid can return to its pre-deformation or uncompacted shape when the compressive force is removed). In some embodiments, the helical grid is flexible. In some embodiments, the helical grid includes two outer edges, and the grid cells are arranged between the two outer edges. In some embodiments, the two outer edges are fixedly attached to the shaft at one or more locations. In some embodiments, one or more locations include the proximal end of the thrombectomy device or the distal end of the thrombectomy device. 【0010】 In some embodiments, the width of the thrombectomy device is approximately 1 mm to approximately 30 mm (e.g., approximately 1 mm to approximately 20 mm, approximately 5 mm to approximately 20 mm, approximately 5 mm to approximately 15 mm, etc.). In some embodiments, the width of the thrombectomy device is periodic along its length. In some embodiments, the length of the thrombectomy device is approximately 10 mm to approximately 600 mm (e.g., approximately 20 mm to approximately 500 mm, approximately 30 mm to approximately 400 mm, approximately 40 mm to approximately 300 mm, approximately 50 mm to approximately 200 mm, approximately 60 mm to approximately 100 mm, or approximately 80 mm, etc.). 【0011】 In some embodiments, the shaft extends through the proximal end of the helical grid and beyond the distal end of the thrombectomy device. In some embodiments, the shaft includes a lumen that extends along the length of the shaft. In some embodiments, the lumen is sized to fit over a guidewire. 【0012】 In some embodiments, the shaft has a bending coefficient of at least 50 MPa. In some embodiments, the shaft is composed of multiple segments. In some embodiments, adjacent segments are configured to bend independently of each other (e.g., 0.01° to 45° relative to each other). In some embodiments, each segment has a length of about 0.1 mm to about 10 mm. 【0013】 In some embodiments, the thrombectomy device is sized to traverse a blood vessel. In other embodiments, the shaft of the thrombectomy device has a length of about 1 cm to about 200 cm (e.g., about 20 cm to about 175 cm, about 30 cm to about 150 cm, about 40 cm to about 125 cm, about 50 cm to about 100 cm, or about 75 cm). In some embodiments, the width of the shaft is about 1 mm to about 30 mm (e.g., about 1 mm to about 20 mm, about 5 mm to about 20 mm, or about 5 mm to about 15 mm). In some embodiments, the thrombectomy device further includes a radiopaque marker. In some embodiments, the helical grid includes a shape memory material. In some embodiments, the shape memory material includes nitinol, steel (e.g., stainless steel), or a shape memory polymer. In some embodiments, the thrombectomy device includes a coating. 【0014】 In some embodiments, the shaft is enclosed within a sheath. In another embodiment, the proximal end of the shaft is enclosed within a housing (for example, the housing includes a handle portion that can be grasped by an operator of the thrombectomy device). In yet another embodiment, the housing includes an actuator for translating the sheath forward and backward along the shaft. In yet another embodiment, the actuator is configured to substantially translate the sheath to the distal end of the thrombectomy device, thereby the sheath covering the thrombectomy device and compressing the helical grid (for example, deforming the helical grid into a shortened shape along a second axis). In yet another embodiment, the thrombectomy device has a distal tip at the distal end that includes a hollow tapered cone or rubber cap that covers the distal end or is blunt. In some embodiments, the shaft is connected to the housing. In some embodiments, the housing includes a sheath, a deployment mechanism configured to retract the sheath, a rotary configured to rotate the shaft and / or the thrombectomy device, and / or an inlet port. 【0015】 In a second embodiment, the disclosure features a delivery system comprising a thrombectomy device of the first embodiment and a housing (for example, a housing located at the proximal end of the shaft of the thrombectomy device, and including a handle portion which can be grasped by an operator of the thrombectomy device and which can be used to operate the thrombectomy device), wherein the housing includes one or more of the following: an inlet port, a guidewire, a pusher, a sheath, a deployment mechanism configured to retract the sheath into the body of the housing, and a rotating body configured to rotate the thrombectomy device. In some embodiments, the shaft of the thrombectomy device is or includes a pusher. In some embodiments, the shaft and / or the thrombectomy device is surrounded by a sheath. In another embodiment, the sheath encloses a helical grid of the thrombectomy device, thereby maintaining or restraining the thrombectomy device in a compressed state. In some embodiments, the shaft is enclosed within the sheath (for example, within the lumen of the sheath). 【0016】 In some embodiments, the system is configured to allow negative pressure (e.g., vacuum pressure) to be applied through one or more inlet ports. In some embodiments, one or more inlet ports are located within a housing at the proximal end of the shaft and are in fluid communication with a sheath surrounding the shaft. In other embodiments, one or more inlet ports are configured to allow fluid, or positive or negative pressure, to be translated from one or more inlet ports to the distal end of the shaft and / or at or near the proximal end of the thrombectomy device. In some embodiments, one or more inlet ports are configured to facilitate the injection of therapeutic agents (e.g., one or more of heparin, tPA, nitroglycerin, and calcium channel blockers) through one or more inlet ports into the thrombectomy device. 【0017】 In a third aspect, the disclosure features a method for removing a thrombus from a blood vessel, comprising: a) inserting a thrombus removal device of the first aspect in a compressed state into a blood vessel; b) advancing the thrombus removal device through the blood vessel and bringing it into contact with the thrombus; b) enabling the thrombus removal device to be changed to an uncompressed state; and c) retracting the thrombus removal device to thereby remove the thrombus. 【0018】 In a fourth aspect, the disclosure features a method for removing a thrombus from a blood vessel, comprising: a) inserting a thrombus removal device of the first aspect in a compressed state into a blood vessel; b) advancing the thrombus removal device through the blood vessel; c) enabling the thrombus removal device to be changed to an uncompressed state; and d) rotating the thrombus removal device about a first axis to thereby fragment or destroy the thrombus. 【0019】 In some embodiments of the third or fourth aspect, the thrombectomy device is located within a delivery system, the delivery system comprising the thrombectomy device and a housing, the housing comprising one or more of an inlet port, a guidewire, a pusher, a sheath, a deployment mechanism configured to retract the sheath into the body of the housing, and a rotating body configured to rotate the thrombectomy device. 【0020】 In some embodiments of the third or fourth aspect, the method further includes providing aspiration to a thrombus. 【0021】 In some embodiments, the thrombectomy device resides within a delivery system comprising the thrombectomy device and one or more of a guidewire, a pusher, and / or a sheath, the sheath of which may include one or more inlet ports. In some embodiments, the lumen of the sheath encloses the thrombectomy device and maintains or restrains the thrombectomy device in a compressed state. In some embodiments, after step b) and before step c), the sheath is retracted. In some embodiments, retracting the sheath includes holding the thrombectomy device in place and pulling the sheath back. 【0022】 In some embodiments, advancing the thrombectomy device within the target vessel includes positioning the thrombectomy device over the distal end of the thrombus (e.g., where the shaft spans the length of the thrombus). In some embodiments, advancing the thrombectomy device within the target vessel includes advancing the thrombectomy device along a guidewire. In some embodiments, advancing the thrombectomy device within the vessel includes applying a biasing force to the proximal end of the thrombectomy device via the shaft, causing the shaft to orient the thrombectomy device proximal. In some embodiments, the method includes changing the position of the thrombectomy device at any point in the method by applying force to the thrombectomy device through the shaft. 【0023】 In some embodiments, the method includes mechanical thrombectomy. In some embodiments, the method includes rotary thrombectomy. 【0024】 In some embodiments, the sheath includes a proximal end and a distal end, the proximal end including an inlet port (for example, the inlet port includes a tube that fluidly connects the inlet port to the sheath). In some embodiments, the method includes aspirating the thrombus through the sheath by applying negative pressure to the inlet port. In some embodiments, the method includes injecting a therapeutic agent through the inlet port and along the sheath, thereby delivering the therapeutic agent to the site of the thrombus. In some embodiments, the therapeutic agent is one or more of heparin, tPA, nitroglycerin, and calcium channel blockers. In some embodiments, the method includes administering the therapeutic agent. 【0025】 In some embodiments, the lumen of the sheath maintains or constrains the thrombectomy device in a compressed state. In some embodiments, after step b) and before step c), the sheath is retracted. In some embodiments, retracting the sheath includes holding the thrombectomy device in place and pulling it back onto the sheath, thereby allowing the thrombectomy device to deploy within the blood vessel and assume its uncompressed state. In some embodiments, advancing the thrombectomy device within the target blood vessel includes advancing the thrombectomy device along a guide wire. 【0026】 In some embodiments, advancing the thrombectomy device within the blood vessel includes applying a force to the proximal end of the thrombectomy device via a shaft. In some embodiments, the shaft of the thrombectomy device includes a lumen configured to conform to a guide wire, and advancing the thrombectomy device along the guide wire includes advancing the shaft along the guide wire. 【0027】 In some embodiments, the method includes changing the position of the thrombectomy device by applying a force to the thrombectomy device through the shaft. In some embodiments, the force is applied to the shaft via a housing. 【0028】 In some embodiments, the blood vessel is a fistula, graft, common carotid artery, internal carotid artery, basilar artery, anterior cerebral artery, middle cerebral artery, posterior cerebral artery, coronary artery, renal artery, or superior mesenteric artery. In some embodiments, the thrombectomy device contacts the wall of the blood vessel at a maximum of four locations (e.g., a maximum of three locations, a maximum of two locations, one location). In some embodiments, the thrombectomy device does not contact the wall of the blood vessel. 【0029】 In a fifth aspect, the present disclosure features a kit that includes the thrombectomy device of the first aspect and one or more additional components. In some embodiments, the one or more additional components include a catheter, a sheath, or a housing (e.g., a housing at the proximal end of the shaft of the thrombectomy device that includes a hand-held portion that can be grasped by an operator of the thrombectomy device and used to manipulate the thrombectomy device). 【0030】 Definitions To facilitate understanding of the present disclosure, several terms are defined below. The terms defined herein have meanings generally understood by those skilled in the art relevant to the present disclosure. Terms such as "a," "an," and "the" are not intended to refer only to a single entity, but include general classes that can be used to illustrate specific examples. The terms herein are used to describe specific embodiments of the present disclosure, but their use is not limiting of the present disclosure, except as outlined in the claims. 【0031】 As used herein, the term "about" refers to a value that is 10% higher or lower than the value being described. 【0032】 As used herein, "rotational thrombectomy" refers to a method in which a thrombus is physically broken down, reduced in size, or fragmented. Rotational thrombectomy may be performed, for example, by rotating a thrombectomy device about an axis parallel to a blood vessel, thereby breaking down the thrombus and restoring flow through the blood vessel. Rotational thrombectomy may use a rotational speed of from about 0.5 rpm to about 5000 rpm. 【0033】 As used herein, “mechanical thrombectomy” refers to a method by which an obstruction (e.g., a blood clot or thrombus) is physically removed from a blood vessel. Mechanical thrombectomy may be performed, for example, by attaching a thrombectomy device to the thrombus, for example by physically bringing the thrombus into contact with the thrombectomy device, and then retracting the thrombectomy device out of the blood vessel, thereby removing the thrombus and restoring blood flow through the vessel. 【0034】 As used herein, “occlusion” refers to any obstruction in the vascular system of interest (e.g., a thrombus, blood clot, or embolism). The obstruction may adhere to the inner wall of a blood vessel. The obstruction may partially or completely restrict blood flow in the vascular system of interest. The presence of an occlusion (e.g., a thrombus) in the vascular system of interest may reduce blood flow to a lower level than that experienced by a healthy subject in the same artery or vein (e.g., an artery or vein without occlusion). In the case of a vein, for example, blood flow may be reduced to less than 30 mL / s, less than 15 mL / s, less than 5 mL / s, less than 1 mL / s, less than 0.5 mL / s, less than 0.1 mL / s, less than 0.05 mL / s, less than 0.04 mL / s, less than 0.03 mL / s, less than 0.02 mL / s, less than 0.01 mL / s, or about 0 mL / s. 【0035】 "To treat" or "treatment" means medical management of an object intended to result in improvement, repair, or prevention of further injury, disease, pathological condition, or impairment. Exemplary injuries, diseases, pathological conditions, or impairments include thrombosis (including arterial thrombosis, venous thrombosis, and deep vein thrombosis, pulmonary embolism, and arterial thrombosis), antiphospholipid syndrome, prothrombin gene mutations, factor V Leiden mutations, protein deficiencies (e.g., protein C, protein S, or ATIII), stroke, heart attack, loss of limb due to amputation, paralysis, hormonal imbalances (e.g., increased estrogen), compression from other organs and / or tumors over the blood vessels, persistent venous injury as a result of frequent venous access, or as a result of fistula or graft formation. In addition, the injury, disease, or disability may be the result of prior medical treatment for the injury, disease, or disability requiring treatment by, for example, hormone therapy, antifibrinolytic agents (e.g., aprotinin, tranexamic acid, etc.), chemotherapeutic agents (e.g., cisplatin and tamoxifen), or endovascular procedures (e.g., angioplasty, atherectomy, stent removal, venous embolization, etc.). Treatment or treatment includes the partial or complete removal of an obstruction (e.g., thrombus) before the subject experiences further adverse health effects resulting from reduced blood flow that leads to an obstruction, for example, myocardial infarction or stroke. Treatment or treatment may further include the application of a chemical composition that assists in the removal of the obstruction and / or prevents the formation of further obstructions. Treatment or treatment includes active treatment, i.e., treatment directed specifically to improve the injury or disease, pathological condition, or disability, and also causal treatment, i.e., treatment directed to eliminate the cause of the injury or disease, pathological condition, or disability. In addition, this term includes palliative treatment, i.e., treatment designed to alleviate symptoms rather than cure an injury or disease, pathological condition, or disability; preventive treatment, i.e., treatment aimed at preventing an injury or disease, pathological condition, or disability; and supportive treatment, i.e., treatment used to complement another specific therapy aimed at improving an injury or disease, pathological condition, or disability. 【0036】 "Blood vessels" means any circulatory conduit in the subject, including but not limited to aortas, arteries, arterioles, capillaries, veins, fistulas, grafts, and stents. 【0037】 When used herein, any value provided in a range of values ​​includes both the upper and lower limits, as well as any value that falls within the upper and lower limits. [Brief explanation of the drawing] 【0038】 The following detailed description of embodiments of this disclosure can be better understood in conjunction with the accompanying drawings. However, it should be understood that this disclosure is not limited to the exact arrangement and means of embodiments shown in the drawings. 【0039】 [Figure 1A-1F] This image shows an embodiment of a thrombectomy device 100, including a helical grid 130 with a proximal end 110, a distal end 120, and grid cells 140 between them, as well as a shaft 170 and a distal connector 180. The device may include a coating 190. Each figure includes a common axial system that highlights the relative orientation of the device exemplified in each figure. Figure 1A shows a side view of the device highlighting the proximal end 110 and distal end 120 of the thrombectomy device 100. Figures 1B-1F show the rotation of the device around the z-axis assigned to Figure 1A. [Figure 2] This is an image of a thrombectomy device, labeled to define its length (L), width (W), and thickness (T), as well as the pitch (P) of one turn of the helical grid. [Figure 3] This is an image of the thrombectomy device 100 partially inserted into the delivery system 200, including the sheath 220. The proximal end 110, shaft 170, and a portion of the helical grid 130 of the thrombectomy device 100 are compressed inside the sheath 220. The distal end 120, distal connector 180, and a portion of the helical grid 130 are not compressed outside the sheath 220. [Figure 4]This is an image of the thrombectomy device 100 partially inserted into the delivery system 200, including the sheath 220. The shaft 170 is fully housed in the sheath 220. [Figure 5] This is an image of a thrombectomy device 100, including a shaft 170. [Figure 6] This image shows a magnified view of the thrombectomy device 100 and the sheath 170, illustrating multiple segments 171 that facilitate the bending and flexibility of the shaft 170. [Figure 7A-7C] Figure 7A shows an image illustrating the connection between the thrombectomy device 100 and the delivery device 200. Figure 7B shows an image illustrating the delivery device 200, including the housing 210, sheath 220, and deployment mechanism 230. Figure 7C shows an image illustrating the shaft 170 and the thrombectomy device 100 compressed within the sheath 220. Figure 7C shows an image illustrating the thrombectomy device 100 after the sheath 220 has been retracted (e.g., by the deployment mechanism 230), allowing the thrombectomy device 100 to expand to an uncompressed state. [Figure 8A-8B] Figure 8A shows an image of the handheld components of the delivery device 200. Figure 8A is an image showing the exterior of the housing 210, including the shaft 170, reinforcement region 211, deployment mechanism 230, rotary actuator 240, and inlet port 250. Figure 8B is a schematic diagram showing the interior of the housing 210, including the shaft 170, reinforcement region 211, deployment mechanism 230, rotary actuator 240, and a rotating body 241, which includes the motor 242 and gear 243. [Figures 9A-9D] These images show the decompression and deployment of the helical grid 130 of the thrombectomy device 100 within the sheath 220 when the deployment mechanism 230 is in operation. Figure 9A shows the thrombectomy device 100 before the sheath 220 retracts. Figures 9B-9D show the gradual expansion and release of the helical grid 130 of the thrombectomy device 100 as the sheath 220 retracts due to the operation of the deployment mechanism 230. [Modes for carrying out the invention] 【0040】 This disclosure generally features devices, systems, methods, and kits for removing intravascular occlusions (e.g., blood clots or thrombi) for, for example, performing thrombectomy. In particular, this disclosure features thrombectomy devices for removing thrombi from hemodialysis access circuits, including, for example, arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs). The device may be a rotary thrombectomy device, which can be used to break down thrombi into smaller fragments. Alternatively, the thrombectomy device may be a mechanical thrombectomy device, which can be used to remove blood clots from arteries or veins, most often arteries of the brain, heart, or other terminal organs. 【0041】 Figure 1A shows a side view of the thrombectomy device 100. Figures 1B-1F show different orientations of the thrombectomy device 100 after rotation around an axis. The thrombectomy device 100 includes a proximal portion, a distal portion, and an intermediate portion, all of which are located between the proximal end 110 and the distal end 120. The intermediate portion of the device includes a helical grid 130, which is made up of a network of grid cells 140 between them. The helical grid 130 may include a first outer edge 150 and a second outer edge 160, with a network of grid cells 140 located between these edges. The proximal end 110 may further include a shaft 170 (see, for example, Figure 5). The shaft 170 may be fixedly connected to the helical grid 130. The shaft 170 may be attached to the helical grid 130 at its proximal end 110 and / or distal end 120, or a portion thereof. The distal end 120 may further include a distal connector 180. If necessary, the shaft 170 may be reversibly connected to the thrombectomy device 100 (for example, at the proximal end 110, by using, for example, a hook-and-loop connection, an attractive connection (e.g., a magnet), or other connection) to switch between thrombectomy devices having different dimensions. 【0042】 The thrombectomy device 100 is defined by its length (L) and width (W) (Figure 2). The length of the thrombectomy device 100 is the distance along a first axis and is defined as the distance between the proximal end 110 and the distal end 120. The length of the thrombectomy device 100 may be approximately 10 mm to approximately 600 mm (for example, approximately 20 mm to approximately 500 mm, approximately 30 mm to approximately 400 mm, approximately 40 mm to approximately 300 mm, approximately 50 mm to approximately 200 mm, approximately 60 mm to approximately 100 mm, or approximately 80 mm). The width of the thrombectomy device is the distance between two points on the thrombectomy device along a second axis perpendicular to the first axis. The width or thickness of the device may be constant along the length of the device or may vary. The width of the thrombectomy device 100 may be approximately 1 mm to 30 mm (for example, approximately 1 mm to 20 mm, approximately 5 mm to 20 mm, approximately 5 mm to 15 mm, etc.). 【0043】 The proximal portion of the thrombectomy device 100 includes the proximal end 110 and the shaft 170. The shaft 170 can be fixedly attached to the proximal end 110 and / or the distal end 120. For example, the first outer edge 150 and the second outer edge 160 can be fixedly attached to the shaft 170 at the proximal end 110. The shaft 170 can then extend along the middle portion of the thrombectomy device 100, which includes the helical grid 130, past the distal end 120. The first outer edge 150 and the second outer edge 160 can both be fixedly attached to the shaft 170 at the distal end 120. The shaft 170 may include a lumen that spans the length of the shaft 170, and the lumen is sized to fit on a guidewire. 【0044】 The intermediate portion of the thrombectomy device 100, including the helical grid 130, may have a length of approximately 10 mm to approximately 600 mm and a width of approximately 1 mm to approximately 30 mm (for example, approximately 1 mm to approximately 20 mm, approximately 5 mm to approximately 20 mm, approximately 5 mm to approximately 15 mm, etc.). The width of the intermediate portion may be periodic along its length. The distal connector 180 may be conical. If conical, the distal connector 180 has a radius of approximately 0.1 to 2.5 mm and a length of approximately 0.5 mm to approximately 5 mm at its widest point. The helical grid may have a width greater than the width of either the shaft 170 or the distal connector 180. 【0045】 The shaft 170 has a length sufficient to navigate the target vascular system from the entry point to the site of occlusion (e.g., thrombus). The shaft 170 may extend through the helical grid of the thrombectomy device. 【0046】 The thrombectomy device 100, for example, the helical grid 130, may include all or part of a shape memory material. The shape memory material may be nitinol, stainless steel, or a shape memory polymer, or may include these (see, for example, US2011 / 0039967, U.S. Patent No. 9,745,402, and U.S. Patent No. 11,453,740, each of which is incorporated herein by reference). The thrombectomy device 100 may be made of two or more materials. The proximal end 110 and the distal end 120 may be made independently of a material having a Young's modulus of at least about 28 GPa (e.g., a Young's modulus in the range of about 10 to about 50 GPa). Any part of the thrombectomy device 100 may be reinforced with a reinforcing material. For example, the connection between the shaft 170 and the helical grid 130 (e.g., at the proximal end 110) may be reinforced with a reinforcing material. The reinforcing material may be a wire, braid, or coil passing through or inside the proximal end 110. The reinforcing material may be a continuous layer on the surface of the proximal end 110. In addition, any area that may be stress-sensitive (e.g., any two components, e.g., the sheath 220 and the housing 210, or the area connecting the shaft 170 and the housing 210) may be reinforced with the reinforcing material. For example, the housing 210 may include a reinforcing region 211 that reduces strain on the connection between the shaft 170 and the housing 210, the sheath 220 and the housing 210, or both. The proximal end 110 and the distal end 120 may be fabricated independently from a flexible material (e.g., silicone rubber). The proximal end 110 may be fixedly attached to the shaft 170. 【0047】 The helical grid 130 includes one or more turns (e.g., 1 to 10 turns, 1 to 5 turns, or 3 turns) along the first axis of the thrombectomy device. Each turn is defined by a pitch (P). The pitch of the helical grid may be 1 mm to 30 mm (e.g., approximately 1 mm to approximately 20 mm, approximately 5 mm to approximately 20 mm, or approximately 5 mm to 15 mm, etc.). The pitch of each turn may be the same or different. The helical grid 130 further includes several grid cells 140, each of which is defined by shape and region. The shapes and / or regions of all grid cells 140 of the helical grid 130 may be identical. The shapes and / or regions of one or more grid cells 140 may differ from one or more other grid cells 140 of the helical grid 130. The helical grid 130 may include more than one, for example, more than two, more than three, more than four, more than five, more than six, more than seven, more than eight, more than nine, more than ten, or other grid cells 140 of different shapes and / or regions. 【0048】 A person skilled in the art may select a thrombectomy device with an appropriate length, width, thickness, number of turns, pitch of one or more turns, grid cell shape, and / or grid cell area for thrombus removal. A person skilled in the art may select the dimensions of the thrombectomy device based, for example, the size of the vessel (see Table 1), the blood flow through and around the vessel (e.g., tortuousness of the vessel), and / or the chronicity of the blood clot (i.e., age) (e.g., less than 2 weeks, 2 to 8 weeks, more than 8 weeks, etc.). 【0049】 The thrombectomy device 100 can be sized to fit within a selected blood vessel. The length or width of the device can vary slightly (for example, from about 1% to 99% of the length or width of the blood vessel, from about 10% to 90%, from about 20% to 80%, from about 30% to 70%, from about 40% to 60%, or from about 50%). For example, the thrombectomy device 100 can be provided in one of many different sizes configured to fit within a target blood vessel. Examples of blood vessels and their sizes are provided in Table 1. Table 1 [Table 1] 【0050】 Examples of blood vessels on which the thrombectomy device 100 may be used include fistulas, grafts, common carotid artery, internal carotid artery, basilar artery, middle cerebral artery, anterior cerebral artery, or posterior cerebral artery, coronary arteries, renal arteries, or superior mesenteric arteries. 【0051】 The thrombectomy device 100 may be sized to fit, for example, within an aorta, artery, arteriole, capillary, vein, fistula, graft, stent, and any other blood vessel described herein. The thrombectomy device 100 may be sized to have limited contact with the vessel wall (e.g., fewer than 5 contact points, fewer than 4 contact points, fewer than 3 contact points, fewer than 2 contact points, or substantially no contact with the vessel wall (e.g., having a width narrower than the width of the target vessel at the occluded site such as a thrombus)). 【0052】 The thrombectomy device 100 can assume a first state (uncompressed or unbent state) and can deform into a second state (compressed or bent state). In the uncompressed state, the thrombectomy device 100 can have a width of approximately 1 mm to approximately 30 mm. In the compressed state, the thrombectomy device 100 can have a width of approximately 0.5 mm to approximately 6 mm (see Figure 3). A thrombectomy device with a width greater than the width of the occluded vessel may be selected. In this case, the compressed thrombectomy device will be uncompressed to an uncompressed state when exposed from the sheath. This expansion may be expansion to an uncompressed state (e.g., expansion so that the device rests against the vessel wall) or expansion to a partially uncompressed state. The partially uncompressed state may have a width greater than the width of the compressed state (e.g., greater than approximately 0.5 mm) and smaller than the width of the uncompressed state (e.g., less than approximately 30 mm). 【0053】 The width of the thrombectomy device 100 in a compressed, uncompressed, or both state may be variable along its length. The thrombectomy device 100 can be deformed into a compressed state when loaded into the sheath 220 (or other material that can constrain the shape of the thrombectomy device 100) of the delivery system 200. The thrombectomy device 100 can then be guided by the delivery system 200 to the site of occlusion (e.g., the thrombus). Once navigated to the site of occlusion, the thrombectomy device 100 may then be unfolded (e.g., removed from the sheath 220, allowing for expansion). 【0054】 The thrombectomy device 100 may be included in a delivery system 200, which includes the thrombectomy device 100 and one or more additional components (see, for example, Figure 3). The delivery system 200 may include a housing 210, a sheath 220 (including a proximal end 221 and a distal end 222), a deployment mechanism 230, a rotary actuator 240, and / or an inlet port 250. The housing 210 may be connected, for example, to the sheath 220, the deployment mechanism 230, the rotary actuator 240, and / or the shaft 170. For example, the deployment mechanism 230 and the rotary actuator 240 may be located on the housing 210, and the proximal end of the sheath 220 and / or the proximal end of the shaft 170 may be connected to the housing 210. The housing 210 may be sized to be held in the operator's hand during a thrombectomy procedure. The housing 210 may act on the shaft 170 so that the shaft 170 functions as a pusher for the delivery system 200. For example, the shaft 170 may be mechanically and / or electronically coupled to the housing so as to advance the housing, thereby advancing the thrombectomy device 100 through the target vascular system. The housing 210 may include means for relieving strain on the shaft 170, sheath 220, or guidewire, for example, by preventing high-strain bending of the shaft 170, sheath 220, or guidewire. For example, the housing 210 may include a reinforcing region 211. 【0055】 The sheath 220 may enclose one or more of the thrombectomy device 100 and the shaft 170. The sheath 220 may enclose all or part of the shaft 170. The sheath 220 may be mechanically or electronically coupled to a deployment mechanism 230. The deployment mechanism 230 is configured such that the operation of the deployment mechanism 230 operates the sheath 220, for example, by retracting the sheath 220 or extending the sheath 220. For example, before deploying the thrombectomy device 100, the sheath 220 encloses the thrombectomy device 100, including the helical grid 130 and the sheath 170. The operating deployment mechanism 220 retracts the sheath 220, thereby releasing the helical grid 130 of the thrombectomy device 100 and allowing the grid cells 150 of the thrombectomy device 100 to expand from a compressed state to an uncompressed state. 【0056】 The system may also include a guidewire that can be used to navigate the thrombectomy device 100 to a target site within the blood vessel. The shaft 170 may include a lumen that spans the length of the shaft 170. If the shaft 170 includes a lumen, the lumen may be sized to fit over the guidewire. 【0057】 The rotary actuator 240 may be mechanically or electronically coupled to the rotating body 241. The rotating body 241 is configured to rotate the shaft 170 and / or guidewire, thereby rotating the thrombectomy device 100 (e.g., around a first axis). The rotating body 241 may include a motor 242 mechanically coupled to one or more gears 243 that contact the shaft 170. The rotating body 241 may rotate the thrombectomy device 100 at a speed of about 0.5 rpm to about 5000 rpm. The rotational speed may be constant, or it may be variable as needed during the thrombectomy procedure and may be adjusted by the operator. 【0058】 spiral lattice As shown in Figures 1A-1F, the thrombectomy device 100 includes an intermediate section having a helical grid 130. The helical grid 130 includes a network of helical cells 140. The helical grid 130 of the thrombectomy device 100 may include approximately 1 to approximately 10 turns (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 turns). Each turn is defined by a pitch P, which is the length along the first axis of the thrombectomy device 100 for the helical grid 130 to complete a single 360° rotation. Each turn may have the same pitch or may have different pitches. For example, each turn may have the same pitch of approximately 1 mm to approximately 30 mm (e.g., 1 mm to approximately 30 mm (e.g., approximately 1 mm to approximately 20 mm, approximately 5 mm to approximately 20 mm, or approximately 5 mm to approximately 15 mm, etc.) or the pitch of each turn may be selected independently from this range (see Figure 2). 【0059】 The helical lattice cells 140 are compressible and may be formed from any of a number of different shapes, such as polygons, squares, rectangles, triangles, rhombuses, circles, ellipses, egg-shaped, oblong, lenticular, star-shaped, delta-shaped, slit-shaped, or amorphous shapes. The shapes and / or regions of all lattice cells 140 in the helical lattice 130 may be identical. The shapes and / or regions of one or more lattice cells 140 may differ from one or more other lattice cells 140 in the helical lattice 130. The helical lattice 130 may contain more than one, for example, more than two, more than three, more than four, more than five, more than six, more than seven, more than eight, more than nine, more than ten, and so on, of lattice cells 140 with different shapes and / or regions. By selecting different shapes and / or regions of the grid cells 140, the flexibility of the thrombectomy device 100, the compressibility of the thrombectomy device 100, or the contact points between the thrombectomy device 100 and the thrombus can be altered. The different shapes and / or regions of the grid cells of the thrombectomy device may be selected by the operator, for example, based on the location of the thrombus or the chronicity of the thrombus. 【0060】 The helical grid 130 may include a first outer edge 150 and a second outer edge 160, with a network of grid cells 140 arranged between these outer edges. The first outer edge 150 and the second outer edge 160 may be connected to form structures, such as a shaft 170 and a distal connector 180, at their proximal and distal ends, respectively. 【0061】 The helical grid 130 can be constrained in a compressed state by being pulled into the sheath 220. The helical grid 130 can then be navigated to the site of the thrombus by the delivery system 200 (for example, by applying force to the helical grid 130 via a shaft 170, both of which are sealed within the lumen of the sheath 220). The helical grid 130 can then be released (e.g., unfolded) from the distal end 222 of the sheath 220, which removes the constraint and allows the device to change to an uncompressed state (e.g., an undeformed or unshortened shape, see Figure 3). For example, if a helical grid slightly larger than the vessel containing the thrombus is selected, the helical grid may be partially expanded to a partially uncompressed state. 【0062】 The helical grid 130 includes a length defined along a first axis. The length of the helical grid 130 may be approximately 10 mm to approximately 600 mm (e.g., approximately 20 mm to approximately 500 mm, approximately 30 mm to approximately 400 mm, approximately 40 mm to approximately 300 mm, approximately 50 mm to approximately 200 mm, approximately 60 mm to approximately 100 mm, or approximately 80 mm). The helical grid 130 includes a width defined along a second axis. This width is approximately 1 mm to approximately 30 mm when the thrombectomy device 100 is in an uncompressible state (e.g., approximately 1 mm to approximately 20 mm, approximately 5 mm to approximately 20 mm, or approximately 5 mm to approximately 15 mm), and approximately 0.5 mm to approximately 6 mm when it is in a compressed state. The width of the helical grid 130 in an uncompressible state may be periodic along its length. The spiral lattice 130 can have a thickness of approximately 0.01 mm to approximately 1 mm (see Figure 2). 【0063】 The spiral grid 130 may further include textures (e.g., bumps, depressions, ridges, etc.). The textures may be located on the inner or outer surface of the spiral grid 130. 【0064】 Shafts and connectors The thrombectomy device 100 may include a shaft 170 and / or a distal connector 180. The shaft 170 may be an elongated cylinder. The distal connector 180 may be circular, semicircular, oval, cylindrical, or hook-shaped. The shaft 170 may be fixedly connected to a helical grid 130 or a portion of the proximal end 110. The shaft may help to force the thrombectomy device 100 through the target vascular system (for example, by functioning as a pusher that can be used to apply a biasing force). The shaft 170 may include lengths of approximately 1 cm to approximately 200 cm (e.g., approximately 20 cm to approximately 175 cm, approximately 30 cm to approximately 150 cm, approximately 40 cm to approximately 125 cm, approximately 50 cm to approximately 100 cm, approximately 75 cm, etc.). 【0065】 The thrombectomy device 100 can be positioned or moved at any point during operation by applying force through the shaft 170. During mechanical thrombectomy, the sheath 220 may be engaged or retracted (e.g., manually or by the deployment mechanism 230) to facilitate the removal of the occlusion (e.g., thrombus). The deployment mechanism 230 can be used to translate the sheath 220 forward and backward along the shaft 170 (e.g., carefully distal and proximal relative to the thrombectomy device 100). Engaging the deployment mechanism 230 and moving the sheath 220 distally can result in sheath accommodation of the thrombectomy device 100 after contact with the thrombus, thereby forcing the thrombectomy device 100 to take on a compressed state within the sheath 220, which also pulls the thrombus within the sheath 220, thereby trapping the thrombus. 【0066】 The shaft 170 may be fixedly attached to the helical grid 130, for example, at its proximal end 110 and / or distal end 120. For example, the first outer edge 150 and the second outer edge 160 may be fixedly attached to the shaft 170 at the proximal end 110. The shaft 170 may then extend along the middle portion of the thrombectomy device 100, including the helical grid 130, past the distal end 120. Both the first outer edge 150 and the second outer edge 160 may be fixedly attached to the shaft 170 at the distal end 120. During rotational thrombectomy, the shaft 170 may be rotated, thereby rotating the helical grid 130 to cool the thrombus. The shaft 170 may be rotated by a rotating body 241 mechanically or electronically coupled to a rotary actuator 240, for example. 【0067】 The shaft 170 may include a lumen that spans the length of the shaft 170, and the lumen is sized to fit over the guidewire. The lumen of the shaft 170 allows the shaft 170 to rotate over the guidewire independently of any rotation of the guidewire, thereby allowing the thrombectomy device 100 to cold-immerse the thrombus without causing any damage or slippage to the guidewire. 【0068】 The shaft 170 may be composed of multiple segments 171. Each segment 171 is configured such that the movement of each segment relative to an adjacent segment (e.g., bending) causes bending within the shaft. For example, adjacent segments 171 may be angled from 0.01° to 45° relative to the adjacent segment (e.g., 0.05° to 30°, 0.1° to 29°, 0.2° to 28°, 0.3° to 27°, 0.4° to 26°, 0.5° to 25°, 0.6° to 24°, 0.7° to 23°, 0.8° to 22°, 0.9° to 21°, or 1° to 20°, or at least 0.01°, at least 0.02°, at least 0.03°, at least 0.04°, at least 0.05°, at least 0.06°, at least 0.08°, at least 0.08°, at least 0.09°). It may be bent by at least 0.1°, at least 0.2°, at least 0.3°, at least 0.4°, at least 0.5°, at least 0.6°, at least 0.7°, at least 0.8°, at least 0.9°, at least 1°, at least 2°, at least 3°, at least 4°, at least 5°, at least 6°, at least 7°, at least 8°, at least 9°, at least 10°, at least 15°, at least 20°, at least 25°, at least 30°, at least 35°, at least 40°, or at least 45°. 【0069】 The shaft 170 has, depending on the length of the shaft 170, for example, at least 10 segments 171 (for example, at least 20, at least 30, at least 40, at least 50, at least 60, at least 70, at least 80, at least 90, at least 100, at least 150, at least 250, at least 300, at least 350, at least 400, at least 450, at least 500, at least 600, at least 700, at least 800, at least 900, and at least... It may consist of multiple interconnected segments 171 from 1000, at least 1500, at least 2000, at least 2500, at least 3000, at least 3500, at least 4000, at least 4500, at least 5000, at least 5500, at least 6000, at least 6500, at least 7000, at least 7500, at least 8000, at least 8500, at least 9000, at least 9500, or at least 10000 segments.Each of the segments 171 may have a length of approximately 0.01 mm to approximately 20 mm (for example, approximately 0.05 mm to 150 mm, approximately 0.1 mm to approximately 100 mm, approximately 0.2 mm to approximately 90 mm, approximately 0.3 mm to approximately 80 mm, approximately 0.4 mm to approximately 70 mm, approximately 0.5 mm to approximately 60 mm, approximately 0.6 mm to approximately 50 mm, approximately 0.7 mm to approximately 40 mm, approximately 0.8 mm to approximately 30 mm, approximately 0.9 mm to approximately 20 mm, approximately 1 mm to approximately 10 mm), or alternatively, each of the segments 171 may have a length of at least approximately 0.01 mm (for example, at least approximately 0.02 mm, at least approximately 0.03 mm, at least approximately 0.04 mm, at least approximately 0.05 mm, at least approximately 0 It may have a length of 0.06 mm, at least about 0.07 mm, at least about 0.08 mm, at least about 0.09 mm, at least about 0.1 mm, at least about 0.2 mm, at least about 0.3 mm, at least about 0.4 mm, at least about 0.5 mm, at least about 0.6 mm, at least about 0.7 mm, at least about 0.8 mm, at least about 0.9 mm, at least about 1 mm, at least about 2 mm, at least about 3 mm, at least about 4 mm, at least about 5 mm, at least about 6 mm, at least about 7 mm, at least about 8 mm, at least about 9 mm, at least about 10 mm, or at least about 20 mm. 【0070】 The segment 171 can increase the flexibility of the shaft 170 compared to a shaft made of the same material without the segment 171 (e.g., a shaft made of a single piece of material). The flexibility of the shaft 170 can be compared by measuring the bending modulus (e.g., the maximum stress that the material can withstand before it breaks). The bending modulus of a shaft 170 composed of multiple segments 171 may be at least 10 MPa (e.g., at least 20 MPa, at least 30 MPa, at least 40 MPa, at least 50 MPa, at least 60 MPa, at least 70 MPa, at least 80 MPa, at least 90 MPa, at least 100 MPa, at least 150 MPa, at least 200 MPa, at least 300 MPa, at least 350 MPa, at least 400 MPa, at least 450 MPa, at least 500 MPa, at least 550 MPa, at least 600 MPa, at least 650 MPa, at least 700 MPa, at least 750 MPa, at least 800 MPa, at least 850 MPa, at least 900 MPa, at least 950 MPa, or at least 1000 MPa). An example of a segment 171 within the shaft 170 is shown in Figure 6. 【0071】 The distal connector 180, if present, may include a hollow tapered cone or rubber cap covering the distal end. Alternatively, the distal connector 180 may be a blunt end that can be used to interact with the thrombus (e.g., to engage with the thrombus) during use of the thrombectomy device 100. If the distal connector 180 is absent, a hollow tapered cone or rubber cap may be present on the distal end of the guidewire. 【0072】 coating The thrombectomy device 100 may include a coating 190 on its surface. The coating 190 contains a compound that can facilitate the removal or destruction of an occlusion (e.g., a thrombus) or the insertion of the thrombectomy device 100 into the target blood vessel. The coating 190 may be a drug, therapeutic agent, lubricant, or adhesive. The coating 190 may also be an anticoagulant (e.g., an antithrombotic agent, a blood thinner, or a solvent (e.g., leteplase, alteplase, etc.)). 【0073】 Radiopaque markers The thrombectomy device 100 may include a radiopaque marker. The radiopaque marker may be located at the proximal end 110 and the distal end 120, for example, along a helical grid 130. Devices combining the thrombectomy device and the radiopaque marker are known in the art (see, for example, U.S. Patent Applications 17 / 168,166, 17 / 235,764, and 13 / 827,208, the full contents of which are incorporated by reference). 【0074】 Delivery system The thrombectomy device 100 may be included with the delivery system 200 (for example, as part of a kit) or used in conjunction with the delivery system 200 (for example, during thrombectomy). The thrombectomy device 100 interacting with the delivery device 200 is shown in Figures 7A–7C. The delivery system 200 can be used to navigate the thrombectomy device 100 to a desired site within the target vascular system. The delivery system 200 includes a housing 210, a sheath 220, a deployment mechanism 230, a rotary actuator 240, and an inlet port 250. 【0075】 The housing 210 may include a handle portion that can be grasped by an operator of the thrombectomy device. The housing 210 may be fixedly mounted to the proximal end of the shaft 170, the sheath 220 (e.g., the proximal end 221 of the sheath 220), the deployment mechanism 230, and / or the rotary actuator 240. The housing 210 may be configured to apply force (e.g., rotational force, force to push the delivery system 200 and the thrombectomy device 100 through the vascular system). The housing 210 may include a hollow or partially hollow body in which the rotating body 241 can be housed. When the sheath 220 is retracted using the deployment mechanism 230, a portion of the sheath 220 may be housed in the hollow body of the housing 210. An inlet port 250 may be connected to the lumen of the sheath 220 within the body of the housing 210. An example of the housing 210, including a sheath 220, a deployment mechanism 230, a rotary actuator 240, and an inlet port 250, is shown in Figures 8A–8B. 【0076】 The housing 210 may also include means for reducing strain at any connection between the housing 210 and the shaft 170 or sheath 220 during bending. For example, the housing 210 may include a reinforcing region 211. The reinforcing region 211 may be a region of material containing the area where the shaft 170 or sheath 220 connects to the housing 210. The material of the reinforcing region 211 may be slightly stiffer and / or less flexible than the material of either the shaft 170 or the sheath 220, thereby reducing the degree to which either the shaft 170 or the sheath 220 can bend relative to the housing 210 during the operation of the thrombectomy device 100. 【0077】 The sheath 220 consists of a proximal end 221 and a distal end 222, and has a length between the proximal end 221 and the distal end 222, and a lumen that spans the length of the sheath 220. The lumen of the sheath 220 may have an outer diameter that is at most the width of the thrombectomy device (e.g., about 1 mm to 30 mm, about 1 mm to 20 mm, about 5 mm to 20 mm, about 5 mm to 15 mm, etc.) and smaller than the diameter of the vessel selected to be operated on. The sheath 220 may be sized to house the thrombectomy device 100 in a compressed state. The sheath 220 may have a length of at least the length of the thrombectomy device (e.g., at least 20 mm, at least 30 mm, at least 50 mm, at least 75 mm, at least 100 mm, at least 150 mm, at least 200 mm, at least 250 mm, at least 300 mm, at least 400 mm, at least 500 mm, at least 600 mm, etc.). The sheath 220 may span the length of the shaft 170 (e.g., lengths of about 1 cm to about 200 cm, about 20 cm to about 175 cm, about 30 cm to about 150 cm, about 40 cm to about 125 cm, about 50 cm to about 100 cm, about 75 cm, etc.). 【0078】 The sheath 220 may be mechanically or electronically coupled to the deployment mechanism 230. An operating deployment mechanism 230 (e.g., a push-down, rotational, or translational deployment mechanism 230) operates the sheath 220, for example, by retracting the sheath 220 into the body of the housing 220 or releasing the sheath 220 from the body of the housing 220 to cover or partially cover the helical grating 130 (for example, after it has engaged with a thrombus). An operating deployment mechanism 230 may include translating the deployment mechanism along a groove in the housing 210 parallel to the shaft 170. A moving deployment mechanism 230 may cause a corresponding movement within the sheath 220. For example, when the deployment mechanism 230 moves away from the proximal end of the thrombectomy device 100 (for example, toward the rear of the housing 210), the deployment mechanism 230 may pull the sheath 220 away from the proximal end of the thrombectomy device 100 toward the rear of the housing, thereby releasing the thrombectomy device 100. An exemplary operation of the delivery system 200 including the sheath 220 is as follows: Prior to the deployment of the thrombectomy device 100, the sheath 220 encloses the thrombectomy device 100, including the helical grid 130 and the sheath 170. The deployment mechanism 230 is then operated to retract the sheath 220, thereby releasing the helical grid 130, thereby allowing the thrombectomy device 100 to expand from a compressed state to an uncompressed state. Figures 9A–9D show the expansion of the thrombectomy device 100 during various stages of the deployment of the helical grid 130. The delivery system 200 may include several components that are suitable for operating the sheath 220. For example, in addition to the deployment mechanism 230, the delivery device may include a further deployment mechanism configured for smaller (finer) incremental control over the retracted sheath than is otherwise provided by the deployment mechanism 230. 【0079】 The delivery system 200 may include a rotary actuator 240 mechanically or electronically coupled to a rotary body 241 housed within the main body of the housing 240. The rotary body 241 is configured to rotate the shaft 170 and / or guidewire, thereby rotating the thrombectomy device 100 (e.g., around a first axis). The rotary body 241 may include a motor mechanically coupled to one or more gears in contact with the shaft 170. The rotary body 241 can rotate the thrombectomy device 100 at a speed of approximately 0.5 rpm to approximately 5000 rpm. The rotational speed may be constant or may be variable as needed during the thrombectomy procedure and may be adjusted by the operator. Any electrical components necessary to operate the rotary body 241 (e.g., circuits necessary for electrical coupling, power supply for the rotary body 241, etc.) may be contained within the main body of the housing 210. 【0080】 The thrombectomy device 100 can optionally be integrated into a composite delivery system, including a sheath and / or other components as described herein, as has been done with other types of thrombectomy devices known in the art (see, for example, U.S. Patents 10,695,159, 10,786,268, 8,734,374, and 5,702,413, and U.S. Patent Application No. 12 / 704,492, in which its sheath is incorporated by reference). 【0081】 The delivery system may further include one or more of the following: a pusher, a guidewire, and a catheter. 【0082】 Suction devices and injectors The delivery system may include an inlet port 250 that is in fluid communication with the lumen of the sheath 220. The inlet port 250 may be mounted on the housing 210 and be in fluid communication with the lumen of the sheath 220. The inlet port 250 may be used as an aspirator (for example, to provide negative pressure near a thrombus) or as an injector (for example, to deliver a therapeutic agent near a thrombus). The inlet port 250 may be used as an aspirator in a method requiring the aspiration of a thrombus (for example, aspiration thrombectomy or suction thrombectomy). When the inlet port 250 is used as an injector, the inlet port may be connected to a reservoir for the therapeutic agent. 【0083】 Methods for performing aspiration or infusion during thrombectomy procedures, as well as devices and components for achieving aspiration and infusion, are known in the Art and can be readily applied to the construction and / or use of the thrombectomy device 100 and delivery system 200 of this Disclosure (see, for example, U.S. Patent Nos. 10,188,409 and 8,105,309, and U.S. Patent Applications Nos. 15 / 233,870 and 15 / 266,233, the entirety of which is incorporated by reference). 【0084】 How to use The thrombectomy device 100 and delivery system 200 can be used, as described herein, to treat occluded vessels (e.g., vessels containing blood clots or thrombi) for example during a thrombectomy procedure. The method can be used to treat or prevent diseases, pathological conditions, or disorders in a subject. Injuries, diseases, pathological conditions, or disorders for which the disclosure may be used in treatment include thrombosis (including arterial thrombosis, venous thrombosis, and deep vein thrombosis, pulmonary embolism, and arterial thrombosis), antiphospholipid antibody syndrome, prothrombin gene mutation, factor V Leiden mutation, protein deficiency (e.g., protein C, protein S, or ATIII), stroke, heart attack, limb loss from amputation, paralysis, hormonal imbalance (e.g., increased estrogen), compression from other organs and / or tumors on the vessel, persistent venous injury as a result of frequent venous access, or as a result of fistula or graft formation. In addition, the injury, disease, or disability may be the result of prior medical treatment for the injury, disease, or disability requiring treatment by, for example, hormone therapy, antifibrinolytic agents (e.g., aprotinin, tranexamic acid, etc.), chemotherapeutic agents (e.g., cisplatin and tamoxifen), or endovascular procedures (e.g., angioplasty, atherectomy, stent removal, venous embolization, etc.). The thrombectomy device 100 can be used to break down or remove substantially linear intravascular occlusions (e.g., blood clots or thrombi). The thrombectomy device 100 can be used to break down or remove substantially nonlinear intravascular occlusions (e.g., irregular vessels). 【0085】 Arterial thrombectomy can be performed using the devices, systems, and methods described herein. Dialysis thrombectomy (for example, thrombectomy to remove blood clots in dialysis fistulas) can also be performed using the devices, systems, and methods described herein. 【0086】 The shape and configuration of the thrombectomy device 100 enable more efficient engagement with the thrombus. The helical grid 130 and helical grid cells 140 increase the number of contact points between the thrombectomy device 100 and the thrombus, creating a larger cross-section of the device and improving adhesion to the thrombus. 【0087】 The thrombectomy device 100 may be fixedly attached to the shaft 170, and both may be enclosed within the lumen of the sheath 220 (the sheath 220 engages to cover the thrombectomy device 100 and can be retracted to deploy the thrombectomy device 100). When the sheath 220 engages with the thrombectomy device 100 (thus causing the thrombectomy device 100 to take on a compressed state), the thrombectomy device 100 can then be guided through the blood vessel to the site of the thrombus. The thrombectomy device 100 may pass through the thrombus or pass over the thrombus (for example, the thrombectomy device 100 and the shaft 170 traverse the thrombus). Next, the thrombectomy device 100 can be deployed to any of the following positions by retracting the sheath 220, for example by pulling back the sheath 220 while holding the thrombectomy device 100 in place (e.g., using the deployment mechanism 230), by pushing the thrombectomy device forward while holding the sheath 220 in place, or by pushing the thrombectomy device 100 forward while pulling back the sheath 220. Once removed from the sheath 220, the thrombectomy device 100 can change from a compressed (deformed) state to an uncompressed (undeformed) state. If necessary, force can be applied to the shaft 170 (e.g., through the pusher or through the housing 210) to change the position of the thrombectomy device 100. This can be used to minimize contact between the thrombectomy device 100 and the blood vessel wall and / or optimize the relative orientation of the thrombectomy device 100 and the thrombus for thrombectomy. 【0088】 Mechanical thrombectomy can be performed using the thrombectomy device 100. When the thrombectomy device 100 is close to or in contact with the thrombe, it may adhere to the thrombe. The helical grid 130 may be modified to include means for adhering to the thrombe, for example, by having a coating 190 containing adhesive, spikes, fibers, etc. Alternatively, the helical grid may physically adhere to the thrombe by engaging one or more of the grid cells 140 with the thrombe. The dimensions in the uncompressed state may be designed to maximize the contact points with the thrombe. The helical grid 130 and the helical grid cells 140 increase the number of contact points between the thrombectomy device 100 and the thrombe, creating a larger cross-section of the device and improving adhesion to the thrombe. The dimensions of the thrombectomy device in the unfolded state (e.g., uncompressed state) may be designed to minimize the number of contact points with the vessel wall. Upon attachment to the thrombus, the thrombectomy device 100 may be re-encased by the sheath 220 (for example, the sheath 220 may be released from the body of the housing 210 by, for example, the deployment mechanism 230), and the sheath 220 may compress the thrombectomy device 100. The thrombectomy device 100 may then be withdrawn from the target vascular system using the shaft 170, thereby also removing the thrombus from the vessel. The process may be repeated one or more times until the thrombus is completely or substantially completely removed. The grid may also be manually rotated one or more times during the thrombectomy procedure and before the re-sheathing and removal of the thrombectomy device 100 to improve engagement with the thrombus (e.g., blood clot). 【0089】 Alternatively, rotational thrombectomy may be performed using a thrombectomy device 100. In this use, the thrombectomy device 100 may be guided distal to the thrombus, for example, so that the shaft 170 traverses the length of the thrombus. The thrombectomy device 100 may then be deployed, for example, by retracting the sheath, and expanded from a compressed state to an uncompressible or partially uncompressible state (depending on the size of the vessel into which the thrombectomy device 100 is deployed). The thrombectomy device 100 may then be activated to immerse the thrombus, for example, by rotating the thrombectomy device 100. The thrombectomy device 100 may be pulled back during rotation so that the thrombus (e.g., blood clot) is immersed in a distal to proximal direction. The process may break down the thrombus into smaller pieces, which may then be removed from the vessel or, after being released from the vascular site, allow to pass into the target vascular system. The thrombectomy device 100 includes a mechanism (e.g., a rotating body that can be operated using an on / off switch located in the housing) for rotating the helical grid 130 about a first axis of the thrombectomy device 100 (e.g., a motor). The thrombectomy device 100 can be held stationary along the long axis of the vessel while the device is being moved non-parallel to the long axis of the vessel, or it can be moved parallel to the long axis of the vessel while the helical grid 130 is rotating. In such a manner, the thrombectomy device can be moved without contacting the wall of the vessel (e.g., the size of the thrombectomy device may be selected for the particular vessel in which the thrombectomy device is used in order to avoid the thrombectomy device rubbing against the side of the vessel during use). 【0090】 Both mechanical and rotational thrombectomy may include a step of aspirating the thrombus using a suction device. During aspiration, the thrombectomy device 100 may be allowed to straddle the thrombus at least partially. The method may include a pause following repeated aspiration steps at a given suction intensity. The suction intensity of each aspiration step may be the same as one or more other suction in different aspiration steps, or each aspiration step may use the same suction intensity. The suction intensity may be approximately 1 kPa to approximately 150 kPa (e.g., approximately 10 kPa to approximately 125 kPa, approximately 20 kPa to approximately 100 kPa, approximately 30 kPa to approximately 75 kPa, approximately 40 kPa to approximately 50 kPa, etc.). Each aspiration step may be performed for a period of time from 1 second to 5 minutes. The suction may include at least two suction steps, for example, at least three suction steps, at least four suction steps, at least five suction steps, at least six suction steps, at least seven suction steps, at least eight suction steps, at least nine suction steps, at least ten suction steps, and so on. 【0091】 This method may further include the step of delivering one or more therapeutic agents near the thrombus through an injector. The one or more therapeutic agents may be administered before, during, or after surgery. 【0092】 The operator may use a guidewire or pusher to assist in positioning the thrombectomy device 100. Alternatively, force may be applied to the shaft 170 to change the position of the thrombectomy device 100 relative to the target vascular system. The operator may choose to position the thrombectomy device 100 to minimize contact with the vessel wall (for example, to contact or not contact the vessel wall in fewer than five locations, fewer than four locations, fewer than three locations, fewer than two locations, or one location). 【0093】 Methods for operating thrombectomy devices are known in the art (see, for example, U.S. Patents 5,766,191, 10,251,739, 11,013,523, 11,026,708, and 10,117,671, and U.S. Patent Application No. 12 / 614,006, the entirety of which is incorporated by reference), and such methods can be readily applied to the operation of the thrombectomy device 100 of this disclosure. In a preferred embodiment, the device does not damage blood vessels during operation. 【0094】 The thrombus removal device 100 can be used to remove thrombi from blood vessels, such as those listed in Table 1. This method can be modified by those skilled in the art as known in the art for use in one of the blood vessels described herein. 【0095】 The thrombectomy device 100 can minimize the risk of endothelial damage, prevent or reduce further thrombus formation, and reduce spasms (e.g., by reducing the number of contact points with the vessel wall, thereby reducing irritation and / or damage to the vessel wall). Using the grid cells of the spiral body of the thrombectomy device, the thrombus can be broken down into smaller fragments (e.g., up to 50% of the original thrombus size, up to 40% of the original thrombus size, up to 30% of the original thrombus size, up to 20% of the original thrombus size, up to 10% of the original thrombus size, up to 5% of the original thrombus size, up to 1% of the original thrombus size, etc.). The reduction in thrombus size can reduce the risk of clinically significant embolism. In addition, the grid cells can engage with portions of the thrombus within the aneurysm and pull them into the main lumen of the sheath 220 for effective cold immersion. 【0096】 kit The disclosure also features a kit comprising a thrombectomy device 100 and one or more additional components such as one or more catheters, guidewires, pushers, access sheaths, guide sheaths, and / or cartridges for loading the thrombectomy device. The kit may also provide equipment for providing vascular access (e.g., vascular access micropuncture set and access sheath; see, for example, U.S. Patent No. 11,027,104, the whole of which is incorporated by reference). In some embodiments, the vascular access sheath is a sheath 220. 【0097】 Manufacturing method This disclosure also features methods for fabricating thrombectomy devices. For example, the thrombectomy devices described herein can be fabricated by a variety of methods, including machining, additive manufacturing (3D printing), laser cutting, shaping, metal injection molding, or a combination thereof. [Examples] 【0098】 The following examples are provided to those skilled in the art to explain how the compositions and methods described herein may be used, prepared, and evaluated, and are intended to be purely illustrative of the invention and not intended to limit the scope of the invention. 【0099】 Example 1: Use of a thrombectomy device A thrombectomy device 100 can be used to treat blood clots in a subject requiring it. The thrombectomy device can be operated through the vascular system of the subject as described herein. When near or in contact with a blood clot, the thrombectomy device 100 may be made deployable (e.g., disengaged from the sheath 220) and changed from a compressed to an uncompressed state. The thrombectomy device 100 can be used to mechanically contain a blood clot (e.g., by gripping or attaching the lattice cells 140 of the spiral lattice 130 to the blood clot and pulling the blood clot back into the sheath 220), or, when in contact with a blood clot, the blood clot can be immersed in smaller fragments by rotating the thrombectomy device 100. Removal or immersion of the blood clot improves the condition of the subject by increasing blood flow through the blood vessels. 【0100】 Other Embodiments Those skilled in the art will see various modifications and variations of the invention described without departing from the scope and spirit of the invention. Although the invention has been described in relation to specific embodiments, it should be understood that the claimed invention should not be excessively limited to such specific embodiments. In fact, various modifications of the described modes for carrying out the invention, which will be obvious to those skilled in the art, are intended to be within the scope of the invention. 【0101】 Other embodiments are described in the claims.

Claims

[Claim 1] A thrombectomy device comprising a proximal end and a distal end defining a first axis, and having a length between the proximal end and the distal end, a) The thrombectomy device comprises a shaft including a helical grid having a proximal end and a distal end along the first axis, wherein the helical grid includes a width extending along a second axis perpendicular to the first axis, b) The helical grid includes a network of grid cells, c) A thrombectomy device in which the helical grid is configured to change between a compressed state and an uncompressed state around the second axis. [Claim 2] The thrombectomy device according to claim 1, wherein the thrombectomy device is sized to traverse a blood vessel. [Claim 3] The thrombectomy device according to claim 1 or 2, wherein the helical grid comprises about 1 to about 25 turns. [Claim 4] The thrombectomy device according to any one of claims 1 to 3, wherein the helical grid comprises approximately 1 to 10 turns. [Claim 5] The thrombectomy device according to any one of claims 1 to 4, wherein the helical grid comprises approximately 1 to 5 turns. [Claim 6] The thrombectomy device according to any one of claims 1 to 5, wherein the helical grid includes approximately 3 turns. [Claim 7] A thrombectomy device according to any one of claims 3 to 6, wherein each turn includes a pitch of approximately 1 mm to approximately 50 mm. [Claim 8] A thrombectomy device according to any one of claims 1 to 7, wherein each turn includes a pitch of approximately 1 mm to approximately 20 mm. [Claim 9] A thrombectomy device according to any one of claims 1 to 8, wherein each turn includes a pitch of approximately 5 mm to approximately 20 mm. [Claim 10] A thrombectomy device according to any one of claims 1 to 9, wherein each turn includes a pitch of approximately 5 mm to 15 mm. [Claim 11] The thrombectomy device according to any one of claims 1 to 10, wherein the grid cells are compressible. [Claim 12] The thrombectomy device according to any one of claims 1 to 11, wherein the grid cells include polygonal, square, rectangular, triangular, rhombus, circular, elliptical, egg-shaped, oblong, lenticular, star-shaped, delta-shaped, slit-shaped, or amorphous shapes. [Claim 13] The thrombectomy device according to any one of claims 1 to 12, wherein the helical grid includes a thickness of about 0.01 mm to about 1 mm. [Claim 14] The thrombectomy device according to any one of claims 1 to 13, wherein the helical grid includes a thickness of about 0.03 mm to about 0.8 mm. [Claim 15] The thrombectomy device according to any one of claims 1 to 14, wherein the helical grid includes a thickness of about 0.05 mm to about 0.6 mm. [Claim 16] The thrombectomy device according to any one of claims 1 to 15, wherein the helical grid includes a thickness of about 0.1 mm to about 0.4 mm. [Claim 17] The thrombectomy device according to any one of claims 1 to 16, wherein the helical grid includes a thickness of about 0.2 mm to about 0.3 mm. [Claim 18] The thrombectomy device according to any one of claims 1 to 17, wherein the helical grid self-expands from the compressed state to the uncompressed state. [Claim 19] The thrombectomy device according to any one of claims 1 to 18, wherein the helical grid is flexible. [Claim 20] The thrombectomy device according to any one of claims 1 to 19, wherein the helical grid includes a first outer edge and a second outer edge, and the first outer edge and the second outer edge are fixedly attached to the shaft at one or more locations. [Claim 21] The thrombectomy device according to claim 20, wherein the first outer edge and / or the second outer edge are attached to the shaft at the proximal end of the helical grid. [Claim 22] The thrombectomy device according to claim 20 or 21, wherein the first outer edge and / or the second outer edge are attached to the shaft at the distal end of the helical grid. [Claim 23] The thrombectomy device according to any one of claims 1 to 22, wherein the width of the thrombectomy device is about 1 mm to about 30 mm when the thrombectomy device is in the uncompressed state. [Claim 24] The thrombectomy device according to any one of claims 1 to 23, wherein the width of the thrombectomy device is approximately 1 mm to approximately 20 mm. [Claim 25] The thrombectomy device according to any one of claims 1 to 24, wherein the width of the thrombectomy device is approximately 5 mm to approximately 20 mm. [Claim 26] The thrombectomy device according to any one of claims 1 to 25, wherein the width of the thrombectomy device is approximately 5 mm to approximately 15 mm. [Claim 27] The thrombectomy device according to any one of claims 1 to 26, wherein the width of the thrombectomy device is periodic along the length. [Claim 28] The thrombectomy device according to any one of claims 1 to 27, wherein the length of the thrombectomy device is approximately 10 mm to approximately 600 mm. [Claim 29] The thrombectomy device according to any one of claims 1 to 28, wherein the length of the thrombectomy device is approximately 20 mm to approximately 500 mm. [Claim 30] The thrombectomy device according to any one of claims 1 to 29, wherein the length of the thrombectomy device is approximately 30 mm to approximately 400 mm. [Claim 31] The thrombectomy device according to any one of claims 1 to 30, wherein the length of the thrombectomy device is approximately 40 mm to approximately 300 mm. [Claim 32] The thrombectomy device according to any one of claims 1 to 31, wherein the length of the thrombectomy device is approximately 50 mm to approximately 200 mm. [Claim 33] The thrombectomy device according to any one of claims 1 to 21, wherein the length of the thrombectomy device is approximately 60 mm to approximately 100 mm. [Claim 34] The thrombectomy device according to any one of claims 1 to 33, wherein the length of the thrombectomy device is approximately 80 mm. [Claim 35] The thrombectomy device according to any one of claims 1 to 34, wherein the shaft extends through the proximal end of the helical grid and beyond the distal end of the thrombectomy device. [Claim 36] The thrombectomy device according to any one of claims 1 to 35, wherein the shaft comprises a lumen extending along the length of the shaft. [Claim 37] The thrombectomy device according to claim 36, wherein the lumen is sized to fit on a guidewire. [Claim 38] The thrombectomy device according to any one of claims 1 to 37, wherein the shaft has a flexural modulus of at least 1 MPa. [Claim 39] The thrombectomy device according to any one of claims 1 to 38, wherein the shaft includes a plurality of interconnected segments. [Claim 40] The thrombectomy device according to claim 39, wherein adjacent segments are configured to bend independently of each other. [Claim 41] The thrombectomy device according to claim 40, wherein two adjacent segments can be bent relative to each other by about 0.01° to about 45°. [Claim 42] A thrombectomy device according to any one of claims 39 to 41, wherein each segment has a length of approximately 0.1 mm to approximately 10 mm. [Claim 43] The thrombectomy device according to any one of claims 1 to 42, wherein the shaft is sized to cross a blood vessel. [Claim 44] The thrombectomy device according to any one of claims 1 to 43, wherein the length of the shaft is approximately 1 cm to approximately 200 cm. [Claim 45] The thrombectomy device according to any one of claims 1 to 44, wherein the length of the shaft is approximately 20 cm to approximately 175 cm. [Claim 46] The thrombectomy device according to any one of claims 1 to 45, wherein the length of the shaft is approximately 30 cm to approximately 150 cm. [Claim 47] The thrombectomy device according to any one of claims 1 to 46, wherein the length of the shaft is approximately 40 cm to approximately 125 cm. [Claim 48] The thrombectomy device according to any one of claims 1 to 47, wherein the length of the shaft is approximately 50 cm to approximately 100 cm. [Claim 49] The thrombectomy device according to any one of claims 1 to 48, wherein the length of the shaft is approximately 75 cm. [Claim 50] The thrombectomy device according to any one of claims 1 to 49, wherein the width of the shaft is about 1 mm to about 30 mm when the thrombectomy device is in the uncompressed state. [Claim 51] The thrombectomy device according to any one of claims 1 to 50, wherein the width of the shaft is approximately 1 mm to approximately 20 mm. [Claim 52] The thrombectomy device according to any one of claims 1 to 51, wherein the width of the shaft is approximately 5 mm to approximately 20 mm. [Claim 53] The thrombectomy device according to any one of claims 1 to 52, wherein the width of the shaft is approximately 5 mm to approximately 15 mm. [Claim 54] The thrombectomy device according to any one of claims 1 to 53, wherein the distal end of the thrombectomy device includes a hollow tapered cone or a rubber cap, or is a blunt end. [Claim 55] A thrombectomy device according to any one of claims 1 to 54, further comprising a radiopaque marker. [Claim 56] The thrombectomy device according to any one of claims 1 to 55, wherein the helical grid includes a shape memory material. [Claim 57] The thrombectomy device according to claim 56, wherein the shape memory material comprises nitinol. [Claim 58] A thrombectomy device according to any one of claims 1 to 57, further comprising a coating. [Claim 59] The thrombectomy device according to any one of claims 1 to 58, wherein the thrombectomy device is enclosed within a sheath. [Claim 60] The thrombectomy device according to any one of claims 1 to 59, wherein the shaft is enclosed within a sheath. [Claim 61] The thrombectomy device according to any one of claims 1 to 60, wherein the shaft is joined to the housing. [Claim 62] The thrombectomy device according to any one of claims 1 to 61, wherein the housing comprises the sheath, a deployment mechanism configured to retract the sheath, the shaft and / or a rotary configured to rotate the thrombectomy device, and / or an inlet port. [Claim 63] A delivery system, (a) A thrombectomy device according to any one of claims 1 to 62, (b) A delivery system comprising a housing, wherein the housing comprises one or more of an inlet port, a guidewire, a pusher, a sheath, a deployment mechanism configured to retract the sheath into the body of the housing, and a rotating body configured to rotate the thrombectomy device. [Claim 64] The delivery system according to claim 63, wherein the sheath comprises the thrombectomy device inside the lumen of the sheath. [Claim 65] The delivery system according to claim 63 or 64, wherein the sheath comprises a proximal end, a distal end, and a lumen, and the shaft of the thrombectomy device is enclosed by the lumen of the sheath. [Claim 66] The delivery system according to claim 65, wherein the inlet port is in fluid communication with the lumen of the sheath at the proximal end of the sheath. [Claim 67] The delivery system according to any one of claims 63 to 66, wherein the inlet port is configured to transmit negative pressure through the inlet port to the distal end of the sheath. [Claim 68] The delivery system according to any one of claims 63 to 67, wherein an inlet port is configured to be in fluid communication with the sheath, to receive an injection of a therapeutic agent through the inlet port, and to transmit the therapeutic agent to the distal end of the sheath. [Claim 69] The delivery system according to claim 68, wherein the therapeutic agent is one or more of heparin, tPA, nitroglycerin, and calcium channel blockers. [Claim 70] The delivery system according to any one of claims 63 to 69, wherein the deployment mechanism is configured to retract the sheath, thereby freeing the thrombectomy device from the lumen of the sheath. [Claim 71] The delivery system according to claim 70, wherein the deployment mechanism is configured to redeploy the sheath, thereby returning the thrombectomy device to the lumen of the sheath. [Claim 72] The delivery system according to any one of claims 63 to 71, wherein the rotating body comprises a motor and one or more gears. [Claim 73] The delivery system according to claim 72, wherein the motor is configured to rotate the thrombectomy device about the first axis. [Claim 74] A method for removing blood clots from blood vessels, a) Inserting the thrombectomy device according to any one of claims 1 to 62 into the blood vessel in the compressed state, b) Advancing the thrombus removal device through the blood vessel and bringing it into contact with the thrombus, c) To enable the thrombectomy device to change to the uncompressible state, d) A method comprising retracting the thrombectomy device, thereby removing the thrombus. [Claim 75] A method for removing blood clots from blood vessels, a) Inserting the thrombectomy device according to any one of claims 1 to 62 into the blood vessel in the compressed state, b) Advancing the thrombus removal device through the blood vessel and bringing it into contact with the thrombus, c) To enable the thrombectomy device to change to the uncompressible state, d) A method comprising rotating the thrombus removal device about the first axis, thereby fragmenting the thrombus. [Claim 76] The method according to claim 74 or 75, wherein the thrombectomy device is located within a delivery system, and the delivery system comprises the thrombectomy device and a housing, the housing comprising one or more of an inlet port, a guide wire, a pusher, a sheath, a deployment mechanism configured to retract the sheath into the main body of the housing, and a rotating body configured to rotate the thrombectomy device. [Claim 77] The method according to claim 66, wherein the sheath comprises a proximal end and a distal end, and the proximal end of the sheath is in fluid communication with the inlet port. [Claim 78] The method according to claim 76 or 77, further comprising aspirating the thrombus by generating negative pressure through the inlet port. [Claim 79] The method according to claim 76 or 77, further comprising injecting a therapeutic agent through the inlet port and delivering the therapeutic agent to the thrombus. [Claim 80] The method according to claim 79, wherein the therapeutic agent is one or more of heparin, tPA, nitroglycerin, and calcium channel blockers. [Claim 81] The method according to any one of claims 64 to 70, wherein in step a), the thrombectomy device is sealed within the lumen of the sheath, thereby maintaining the thrombectomy device in the compressed state. [Claim 82] The method according to any one of claims 64 to 71, wherein the sheath is retracted after step b) and before step c). [Claim 83] The method according to claim 82, wherein retracting the sheath includes holding the thrombectomy device in a predetermined position and pulling it back onto the sheath. [Claim 84] The method according to claim 82 or 83, wherein the sheath is retracted by the operation of the deployment mechanism. [Claim 85] The method according to any one of claims 74 to 84, wherein advancing the thrombectomy device within the target blood vessel includes advancing the thrombectomy device along the guide wire. [Claim 86] The method of claim 85, wherein the shaft of the thrombectomy device includes a lumen configured to fit the guidewire, and advancing the thrombectomy device along the guidewire includes advancing the shaft along the guidewire. [Claim 87] The method according to any one of claims 74 to 86, wherein advancing the thrombectomy device within the blood vessel includes applying force to the proximal end of the thrombectomy device via the shaft. [Claim 88] The method according to claim 87, wherein the force is applied to the shaft via the housing. [Claim 89] The method according to any one of claims 74 to 88, further comprising advancing the thrombectomy device so that the thrombectomy device is positioned distal to the thrombus. [Claim 90] The method according to any one of claims 74 to 89, further comprising changing the position of the thrombectomy device at any point in the method by applying force to the thrombectomy device through the shaft. [Claim 91] The method according to any one of claims 74 to 90, wherein the blood vessel is a fistula, a graft, a common carotid artery, an internal carotid artery, a basilar artery, anterior cerebral artery, a middle cerebral artery, or a posterior cerebral artery, a coronary artery, a renal artery, or a superior mesenteric artery. [Claim 92] The method according to any one of claims 74 to 91, wherein the thrombectomy device contacts the wall of the blood vessel at up to four locations. [Claim 93] The method according to any one of claims 74 to 92, wherein the thrombectomy device contacts the wall of the blood vessel at up to three locations. [Claim 94] The method according to any one of claims 74 to 93, wherein the thrombectomy device contacts the wall of the blood vessel at up to two locations. [Claim 95] The method according to any one of claims 74 to 94, wherein the thrombectomy device contacts the wall of the blood vessel at a maximum of one location. [Claim 96] The method according to any one of claims 74 to 95, wherein the thrombectomy device does not come into contact with the wall of the blood vessel. [Claim 97] A kit comprising a thrombectomy device according to any one of claims 1 to 62, and one or more components. [Claim 98] The kit according to claim 97, wherein the one or more additional components include a catheter, a guidewire, a pusher, a sheath, and a housing. [Claim 99] The kit according to claim 98, wherein the housing further comprises one or more of an inlet port, a sheath, a deployment mechanism configured to retract the sheath into the main body of the housing, and a rotating body configured to rotate the thrombectomy device.

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